Essential Formulations Current Affairs

The national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has notified prices of 65 essential formulations, including those used for treatment of diabetes, pain, infections and high blood pressure. The 65 essential formulations fall under scheduled I formulations under Drugs (Prices Control) Order (DPCO), 2013.

Key Facts

All manufacturers of scheduled formulations, selling branded or generic or both versions of scheduled formulations (drugs) at price higher than ceiling price as fixed and notified by Government, have to revise prices downward to the ceiling price cap.

Moreover, manufacturers of these 65 formulations have to furnish quarterly returns to NPPA through IPDMS (Integrated Pharmaceutical DataBase Management System). Besides, any manufacturer intending to discontinue production of any of 65 drugs has to furnish information to NPPA, with respect to discontinuation of production of drug or its import, at least six months prior to intended date of discontinuation.

National Pharmaceutical Pricing Authority (NPPA)

NPPA is independent body under Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers. It was set up in 1997. Its mandate is to fix/revise controlled bulk drugs prices and formulations, enforce prices and availability of medicines under DPCO, 2013.

NPPA fixes ceiling price of essential medicines of Schedule I under DPCO 2013. The calculation for essential drugs is based on simple average of all medicines in particular therapeutic segment with sales of more than 1%. In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10% annually.